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Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

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Reporting Groups

Description

Placebo

Matching placebo

Eltrombopag 75 mg

Eltrombopag 75 mg administered orally once daily

Total

Total of all reporting groups

Baseline Measures

Placebo

Eltrombopag 75 mg

Total

Overall Participants Analyzed [Units: Participants]

147

145

292

Age [Units: Years]Mean (Standard Deviation)

53.5 (11.78)

51.6 (11.04)

52.5 (11.44)

Gender [Units: Participants]

Female

55

49

104

Male

92

96

188

Race/Ethnicity, Customized [Units: Participants]

White

93

85

178

Central/South Asian Heritage

33

41

74

Japanese/East Asian/South East Asian Heritage

19

14

33

African American/African Heritage

2

4

6

Native Hawaiian/Other Pacific Islander and White

0

1

1

Number of participants categorized into the indicated Child-Pugh (CP) Class [1] [Units: Participants]

Child-Pugh Class A

59

68

127

Child-Pugh Class B

64

57

121

Child-Pugh Class C

17

10

27

[1]

The CP score (ranging from 5 to 15; 5=mild, 15=severe), calculated based on total bilirubin, serum albumin, international normalized ratio, ascites, and hepatic encephalopathy, is used to assess liver disease severity. A CP score of 5 or 6 is classified as Class A (mild), a score of 7-9 is classified as Class B (moderate), and a score >=10 is classified as Class C (severe). Participants with a CP score <10 were enrolled in the study. The number of participants analyzed is 140 for placebo and 135 for Eltrombopag; not all participants were compliant and had their baseline CP score measured.

Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures [ Time Frame: Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26 ]

Number of Participants With a World Health Organization (WHO) Bleeding Score >=2 During and up to 7 Days Following Elective Invasive Procedures [ Time Frame: Prior to, during, and up to 7 days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26 ]

Number of Participants With the Indicated Number of Platelet Transfusions Administered [ Time Frame: Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26 ]

Number of Participants With the Indicated Platelet Count at Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 Day Follow-up (FU); and Maximum Post-baseline

Measure Description

Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable).

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

ITT Population. The number of participants analyzed decreases over time due to missing measurements and to participants dropping out of the study.

Reporting Groups

Description

Placebo

Matching placebo

Eltrombopag 75 mg

Eltrombopag 75 mg administered orally once daily

Measured Values

Placebo

Eltrombopag 75 mg

Participants Analyzed [Units: Participants]

147

145

Number of Participants With the Indicated Platelet Count at Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 Day Follow-up (FU); and Maximum Post-baseline [Units: Participants]

Screening, <50 Gi/L, n=147, 145

133

136

Screening, >=50-<=80 Gi/L, n=147, 145

14

8

Screening, >80-<=200 Gi/L, n=147, 145

0

0

Screening, >200-<=400 Gi/L, n=147, 145

0

0

Screening, >400 Gi/L, n=147, 145

0

0

Day 8, <50 Gi/L, n=139, 135

98

48

Day 8, >=50-<=80 Gi/L, n=139, 135

34

50

Day 8, >80-<=200 Gi/L, n=139, 135

7

33

Day 8, >200-<=400 Gi/L, n=139, 135

0

3

Day 8, >400 Gi/L, n=139, 135

0

0

Day 15, <50 Gi/L, n=132, 131

98

14

Day 15, >=50-<=80 Gi/L, n=132, 131

26

31

Day 15, >80-<=200 Gi/L, n=132, 131

8

67

Day 15, >200-<=400 Gi/L, n=132, 131

0

19

Day 15, >400 Gi/L, n=132, 131

0

0

Procedure + 7 Day FU, <50 Gi/L, n=128, 126

78

11

Procedure + 7 Day FU, >=50-<=80 Gi/L, n=128, 126

38

20

Procedure + 7 Day FU, >80-<=200 Gi/L, n=128, 126

12

60

Procedure + 7 Day FU, >200-<=400 Gi/L, n=128, 126

0

30

Procedure + 7 Day FU, >400 Gi/L, n=128, 126

0

4

Procedure + 14 Day FU, <50 Gi/L, n=117, 125

63

22

Procedure + 14 Day FU, >=50-<=80 Gi/L, n=117, 125

40

21

Procedure + 14 Day FU, >80-<=200 Gi/L, n=117, 125

11

62

Procedure + 14 Day FU, >200-<=400 Gi/L, n=117, 125

2

17

Procedure + 14 Day FU, >400 Gi/L, n=117, 125

0

3

Procedure + 21 Day FU, <50 Gi/L, n=121, 117

80

38

Procedure + 21 Day FU, >=50-<=80 Gi/L, n=121, 117

30

33

Procedure + 21 Day FU, >80-<=200 Gi/L, n=121, 117

10

38

Procedure + 21 Day FU, >200-<=400 Gi/L, n=121, 117

0

7

Procedure + 21 Day FU, >400 Gi/L, n=121, 117

0

1

Maximum Post-Baseline, <50 Gi/L, n=144, 140

60

11

Maximum Post-Baseline, >=50-<=80 Gi/L, n=144, 140

53

23

Maximum Post-Baseline, >80-<=200 Gi/L, n=144, 140

28

62

Maximum Post-Baseline, >200-<=400 Gi/L, n=144, 140

3

37

Maximum Post-Baseline, >400 Gi/L, n=144, 140

0

7

No statistical analysis provided for Number of Participants With the Indicated Platelet Count at Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 Day Follow-up (FU); and Maximum Post-baseline

6. Secondary:

Number of Participants Experiencing an Adverse Event (AEs) and Serious Adverse Event (SAEs) Within the Indicated Category [ Time Frame: Screening to Procedure +30 day follow-up or early withdrawal ]

Mean Number of Days Spent in the Hospital [ Time Frame: Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26 ]

Mean Number of Unscheduled Office Visits, Unscheduled Laboratory Tests, and Unscheduled Procedures [ Time Frame: Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26 ]